Which of the following statements in reference to the Policy on Manufacturing and Compounding Products in Canada would be considered manufacturing of a sterile product? a. There is specific authorization for a compounded product on the clinical trial application. b. The compounded product is produced and sold to a third party. c. The compounded product is a formulation that is legitimately different from a similar commercial product. d. The compounded product demonstrates that a patient–health care professional relationship exists.

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Which of the following statements in reference to the Policy on Manufacturing and Compounding Products in Canada would be considered manufacturing of a sterile product?

a.

There is specific authorization for a compounded product on the clinical trial application.

b.

The compounded product is produced and sold to a third party.

c.

The compounded product is a formulation that is legitimately different from a similar commercial product.

d.

The compounded product demonstrates that a patient–health care professional relationship exists. 

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